FDA Registration
Active
🇻🇳 Vietnam
KOOLCARE MEDICAL EQUIPMENT (VIETNAM) COMPANY LIMITED
Reg #: 3040274588
·
FEI: 3040274588
·
Expires 2026
Products
6
Proprietary Names
6
Establishment Types
3
Classifications
6
Research this establishment in seconds
The Research Assistant profiles FDA-registered establishments — listings, owners, related facilities — and cites every record.
Free to try · every answer cites its records
Registration Details
- Registration Name
- KOOLCARE MEDICAL EQUIPMENT (VIETNAM) COMPANY LIMITED
- Registration Number
- 3040274588
- FEI Number
- 3040274588
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Factory A-17A-4-B,C, Lot A-17-CN, NX4 Road, Bau Bang Industrial Park, Bau Bang Commune
- City
- Ho Chi Minh City
- Country
- VN
Owner / Operator
- Firm Name
- Koolcare Medical Equipment (Vietnam) Company Limited
- Operator Number
- 10093838
- Address
- Factory A-17A-4-B,C, Lot A-17-CN, NX4 Road, Bau Bang Industrial Park, Bau Bang Commune
- City
- Ho Chi Minh City
- State
- VN-SG
- Postal Code
- 75000
- Country
- VN
- Correspondent
- Peter Gao
US Agent
- Business Name
- J & F Technology Service
- Contact Name
- Fanny Zhao
- Address
- 19838 Moon Shadow Circle
- City
- Walnut
- State
- CA
- ZIP
- 91789
- Country
- US
- [email protected]
- Phone
- 909 5100201
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2025-07-21 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2025-07-21 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2025-07-21 |
| Pack, Heat, Moist | IMA | Class 1 | Physical Medicine | No | 2025-07-21 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2025-07-21 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2025-07-21 |
Proprietary Names
Pack, hot or cold, reusable
ORTHOSIS, LUMBAR
JOINT, ANKLE, EXTERNAL BRACE
PACK, HEAT, MOIST
JOINT, KNEE, EXTERNAL BRACE
PACK, HOT OR COLD, DISPOSABLE
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)